Kornimate/medical-research-clean huggingface dataset:
a retrospective study with prospective follow-up of complex ventral hernia repair utilizing the allomax surgical graft

Conditions: Hernia

Summary: this study will enroll subjects who underwent a ventral hernia repair using the allomax surgical graft at least 9 months in the past. all subjects who underwent a ventral hernia repair using the allomax surgical graft at least 9 months in the past will be contacted and asked to take part in this clinical study. the consented subjects' medical records will be reviewed for evidence of any risk factors of hernia recurrence, procedure time, complications and any documented recurrences. the subjects will be asked to undergo a physical exam to rule out any recurrences that were not documented in the medical records.

study protocol was amended in june of 2011 to exclude further enrollment of subjects who underwent ventral hernia repair with the allomax surgical graft to bridge hernia defects.

Eligibility criteria:
inclusion criteria: * have undergone a ventral hernia repair using the allomax surgical graft at least 9 months in the past. (june 2011 protocol amendment further specified inclusion of subjects who have undergone a non-bridging hernia repair.) * have signed an informed consent form (icf). exclusion criteria: * underwent implantation of the allomax surgical graft for any reason other than ventral hernia repair. * june 2011 protocol amendment added: used allomax surgical graft to bridge a defect.
probe investigation of the safety & efficacy of telmisartan (micardis®) vs ramipril (altace®) using abpm in htn

Conditions: Hypertension

Summary: demonstrate that telmisartan 80mg was at least as effective and possibly superior to ramipril 5mg \& 10mg in lowering mean ambulatory dbp and sbp during the last 6 hrs of the 24-hr dosing interval in mild-to-moderate hypertensives at the end of 8 and 14 week treatment phases.


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent in accordance with good clinical practice (gcp) and local legislation. * mild-to-moderate hypertension defined as a mean seated diastolic blood pressure of ≥95 mmhg and ≤109 mmhg, measured by manual cuff sphygmomanometer at visit 2. * age 18 years or older (or 19 years if dictated by local state/province policies). * ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion). * 24-hour mean dbp of ≥85 mmhg at visit 3 as measured by ambulatory blood pressure monitoring (abpm). exclusion criteria: * pre-menopausal women (last menstruation ≤1 year prior to signing informed consent) who: * were not surgically sterile; or * were nursing, or * were of childbearing potential and were not practicing acceptable methods of birth control, or did not plan to continue practicing an acceptable method throughout the study. acceptable methods of birth control included iud, oral, implantable or injectable contraceptives. no exceptions were made. * night shift workers who routinely slept during the daytime and whose work hours included midnight to 4:00 a.m. * mean seated sbp ≥180 mmhg or mean seated dbp ≥110 mmhg during any visit of the placebo run-in period. * known or suspected secondary hypertension (e.g., phaeochromocytoma). * hepatic and/or renal dysfunction as defined by the following laboratory parameters: * serum glutamate-oxaloacetate-transaminase (aspartate aminotransferase) (sgot (ast)) or serum glutamate-pyruvate-transaminase (alanine aminotransferase) (sgpt (alt)) \>2 times the upper limit of normal range, or * serum creatinine \>2.3 mg/dl (or \>203 μmol/l). * bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney. * clinically relevant sodium depletion, hypokalaemia or hyperkalaemia. * uncorrected volume depletion. * further exclusion criteria apply
home assessment of blood pressure in pregnancy

Conditions: Hypertensive Disorder of Pregnancy

Summary: the goal of this observational study is to evaluate the feasibility and safety of a comprehensive home blood pressure telemonitoring (hbpt) program for pregnant people with hypertensive disorders of pregnancy (hdp). participants will receive training on the use of a home bp telemonitor with tele-transmission function for the remainder of their pregnancy and 6 weeks postpartum. participating obstetric internal medicine (obim) clinicians will monitor the transmitted values and adjust anti-hypertensive medications based on the home bp readings. our primary goal is to describe the feasibility and safety of a comprehensive hbpt pilot program in british columbia, canada (bc). secondary research questions will address: 1. what is the end-user acceptability of a comprehensive hbpt pilot program in bc? 2. what are the effects of a comprehensive hbpt pilot program on factors such as: 1. maternal and neonatal outcomes 2. home blood pressure (bp) metrics 3. process measures 4. anti-hypertensive medications 5. fidelity to interventions 6. health care utilization


Eligibility criteria:
inclusion criteria: * adult patients aged ≥ 19 years * pregnancy * gestational age 20+0 to 36+0 weeks gestational age * diagnosed with gestational hypertension (defined as sbp ≥140 mm hg and/or dbp ≥ 90 mm hg) after 20 weeks gestation or chronic hypertension (defined as sbp ≥140 mm hg and/or dbp ≥ 90 mm hg), present at booking or before 20 weeks gestation, or receiving treatment (including lifestyle measures) prior to pregnancy and/or at time of referral or transient elevated office bp reading (defined as one time reading of sbp ≥140 mm hg and/or dbp ≥ 90 mm hg with risk factors for hdp as per canadian guidelines). * participant is willing and able to give informed consent for participation in the study * able and willing to comply with study requirements * has smart phone exclusion criteria: * anticipated inpatient admission * remaining pregnancy less than 2 weeks duration * imminent delivery (within the next 48 hours) * non-english speaking or no family members who can help translate
hypothermia's effect on hepatitis b vaccination

Conditions: Hypoxic-Ischemic Encephalopathy; Hepatitis B Vaccination; Hypothermia, Newborn

Summary: the purpose of the research is to determine if the hepatitis b vaccine after birth provides enough protection after cooling for hypoxic ischemic encephalopathy (hie). to do this, hepatitis b titers (blood sample) would be taken before, during, and after administering of the hepatitis b vaccine series to measure efficacy of the vaccine.

despite the current research on hypoxic ischemic encephalopathy (hie), and the known effects of hypothermia on acute immune response, the effect of the hypothermia protocol for hie on the efficacy of the hepatitis b vaccine is still unknown. we plan to measure anti-hepatitis b surface antibodies at intervals prior, during, and after the primary hepatitis b vaccine schedule for individuals with hie to see if there is any effect on efficacy due to the hypothermia protocol.

Eligibility criteria:
inclusion criteria: * \> 34 weeks' gestation at birth as measured by best obstetrical estimates * \> 1500 grams birth weight * clinical signs of asphyxia or documented periods of hypoxic ischemia with no cyanotic cardiac malformations and no known congenital infections. * documented period of hypoxic ischemia: * venous cord gas ph \< 7.0 or initial newborn blood gas ph \< 7.1 * base deficit \> 13 on venous cord gas or initial newborn blood gas * apgar score \< 5 at 10 minutes * prolonged, sustained fetal bradycardia (hr \ 15 minutes in utero by doppler or fetal heart rate monitoring * need for continued resuscitation after 5 minutes (bag-valve mask ventilation with/or without chest compressions) due to the absence of respiratory effort * documented postnatal oxygen saturation \ 20 minutes by 2 abgs, not due to cyanotic heart disease, accompanied by hypotension (mean bp\< 35), cardiac arrest with chest compressions, or hemorrhage (requiring 20cc/kg volume replacement) * parental willingness for infant to receive hepatitis b vaccine. exclusion criteria: - positive maternal hepatitis b status during pregnancy

Keywords: hypoxic ischemic encephalopathy hepatitis b vaccination
variables that are correlated to developing multiple endocrine neoplasia (men) and pancreatic neuroendocrine tumors (pnet)

Conditions: Multiple Endocrine Neoplasia; Pancreatic Neuroendocrine Tumors; Hyperparathyroidism

Summary: the study aims to identify predictors of disease in patients with hyperparathyroidism (hpth) who undergo surgery.

researchers aim to identify somatic mutations and inherited genetic variants which may help predict the development of pnet in patients with hyperparathyroidism.

Eligibility criteria:
inclusion criteria: 1. men1 patients who have undergone parathyroidectomy and did not develop pnet. 2. men1 patients who have undergone parathyroidectomy and had surgical removal of pnet. exclusion criteria: n/a

Keywords: multiple endocrine neoplasia pancreatic neuroendocrine tumors hyperparathyroidism hpth pnet biomarkers parathyroidectomy genome sequencing data review
effect of low protein diet on top of dapagliflozin on chronic kidney disease in patients with type 2 diabetes mellitus

Conditions: Chronic Kidney Diseases; Type 2 Diabetes Mellitus

Summary: this is a prospective multicenter randomized controlled trial with a total duration of 36 months aiming to evaluate the effectiveness and the safety of low protein diet on top of sodium-glucose cotransporter 2 inhibitors (sglt2i) and renin-angiotensin-aldosterone inhibitors (raasi) in reducing the progression of chronic kidney disease in patients with type 2 diabetes mellitus

the kdigo diabetes in ckd guideline (2020) recommends the use of sglt2i (level 1a) and suggests (level 2c) the prescription of plant protein-based low-protein diet in patients with chronic kidney disease (ckd) and diabetes mellitus (dm). both interventions have shown synergistic nephroprotective effects, slowing the progression of chronic kidney disease by reducing glomerular hyperfiltration and proteinuria, thus resulting the hypothesis that by combining these two interventions it could be possible to achieve a superior control over the progression of diabetic kidney disease. the nutritional intervention will consist in a mild protein restriction (0.6 g/kg dry ideal body weight) and a total recommended energy intake of 30-35 kcal/kg of ideal dry body weight per day in all patients. the protein intake will be checked through the food diary and calculated based on urea from 24 hours urine collection. the efficacy and safety parameters will be evaluated during follow-up visits at month 1,2,3,6,12 and 18.

Eligibility criteria:
inclusion criteria: * age\>18 years old * confirmed chronic kidney disease (with egfr between 60 and 20 ml/min/1.73 m2 and/or proteinuria \>500 mg/g urinary creatinine) and confirmed type 2 diabetes mellitus * stable kidney function for at least 12 weeks before enrollment (defined as decrease in egfr \< 5 ml/min/1.73 m2/year according to kdigo 2012 guideline) * treatment with ace/arbs and/or mras for at least 3 months * no previous treatment with sglt2i * good nutritional status * declared and anticipated good compliance with the prescribed diet * signed informed consent exclusion criteria: * egfr \< 25 ml/min/1.73 m2 * poorly controlled arterial blood pressure (mean bp≥145/85 mm hg) * class iv nyha heart failure, recent mace (less than 6 months) * relevant comorbid conditions (active infections (hbv, hcv, hiv), active neoplasia, digestive diseases with malabsorption, active autoimmune diseases/ immunosuppressive therapy) * adpkd * kidney transplantation with functional graft * malnutrition: bmi\ 10% during the last 6 months, serum albumin \<3 g/dl * feeding inability (anorexia, nausea)

Keywords: chronic kidney disease low protein diet nutrition therapy
weekly paclitaxel and cisplatin to treat hormone receptor positive and triple negative breast cancer patients

Conditions: Tubular Breast Cancer; Mucinous Breast Cancer; Invasive Ductal Breast Cancer; Inflammatory Breast Cancer

Summary: the investigators hypothesize that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer. in patients with some sub-type advanced breast cancer, neo-adjuvant chemotherapy combined with endocrine therapy may improve the pathological remission rate. premenopausal patients with triple negative breast caner and hormonal receptor positve breast cancer patients will be randominzed to have neoadjuvant chemotherapy combined with endocrine therapy or not.

in this trial, patients with er and or pr positive breast cancer will be separately randomized to have chemotherapy or chemotherapy combined with endocrine therapy according to their menstrual status. letrozole for the postmenopausal women and ovarian function suppression for the premenopausal women. patients with triple negative breast cancer will be randomized to have neoadjuvant chemotherapy combined with ovarian function suppression if she is premenopausal. postermenopausal patients with triple negative breast caner will only have neoadjuvant chemotherapy. patients with her2 overexpression can obtain anti-her2 target therapy. this study has been amended to a 1:2 ratio to control and neoadjuvant chemotherapy combination of endocrine therapy.

Eligibility criteria:
inclusion criteria: 1. women aged ≥18years and ≤70 years; 2. at least on measurable disease according to the response evaluation criteria in solid tumors (recist). histologically confirmed invasive breast cancer, tumor size ≥2 cm, t2-4 n0-3m0; 3. er/pr/her-2 and ki-67 status detected on core biopsy. er and/or pr positive was defined as \>1% stained cells.her2-positive is defined as immuno-histochemistry (ihc) 3+ or the ratio of her2 gene signals to chromosome 17 signals \>2.0 or her2 gene copy \>6.0. 4. no prior systemic or loco-regional treatment of breast cancer; 5. adequate bone marrow function:wbc≥4.0×109/l, absolute neutrophil count（anc）≥1.5×109/l, platelets（plt）≥100×109/l, hemoglobin（hb）≥90g/l;aspartate aminotransferase(ast),alanine aminotransferase (alt)≤1.5 upper normal limit (unl), creatinine≤1.5 unl, bilirubin≤1.5unl; 6. no obvious main organs dysfunction. exclusion criteria: 1. unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug; 2. patient is pregnant or breast feeding; 3. inflammatory breast cancer and metastatic breast cancer; 4. any evidence of sense or motor nerve disorders; 5. patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection; 6. any concurrent malignancy other than breast cancer; 7. know severe hypersensitivity to any drugs in this study.
single-blind study of a single dose of peginterferon lambda-1a compared with placebo in outpatients with mild covid-19

Conditions: COVID-19

Summary: to evaluate the efficacy of a single dose of subcutaneous injections of 180 ug of peginterferon lambda-1a, compared with placebo in reducing the duration of viral shedding of sars-cov-2 virus in patients with uncomplicated covid-19 disease.

patients will attend up to 9 study visits over a period of up to 28 days.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years and ≤ 75 years at the time of the assessment 2. able and willing to understand the study, adhere to all study procedures, and provide written informed consent 3. diagnosis of covid-19 disease: 1. if symptomatic, the presence of mild to moderate symptoms without signs of respiratory distress, with fda-cleared molecular diagnostic assay positive for sars-cov-2 within 72 hours from swab to the time of commencing informed consent: 2. if asymptomatic, initial diagnosis of sars-cov-2 infection with positive fda-cleared molecular diagnostic assay obtained no more than 72 hours from initial swab to the time of commencing informed consent exclusion criteria: 1. patients who are hospitalized for inpatient treatment or currently being evaluated for potential hospitalization at the time of initiation of informed consent 2. patients with a known allergy to peginterferon lambda-1a or any component thereof 3. display symptoms of respiratory distress (respiratory rate \>20, room air oxygen saturation of \<94%.) 4. participation in a clinical trial with or use of any investigational agent within 30 days before screening 5. treatment with interferons (ifn) within 12 months before screening 6. previous use of peginterferon lambda-1a 7. history or evidence of any intolerance or hypersensitivity to ifns or other substances contained in the study medication. 8. female patients who are pregnant or breastfeeding. male patients must confirm that their female sexual partners are not pregnant. 9. current or previous history of decompensated liver disease (child-pugh class b or c) or hepatocellular carcinoma 10. co-infected with human immunodeficiency virus (hiv) 11. significant abnormal laboratory test results at screening. 12. other significant medical condition that may require intervention during the study 13. concurrent use of any of the following medications: 1. therapy with an immunomodulatory agent 2. current use of heparin or coumadin 3. received blood products within 30 days before study randomization 4. use of hematologic growth factors within 30 days before study randomization 5. systemic antibiotics, antifungals, or antivirals for treatment of active infection within 24 hours before study randomization 6. any prescription or herbal product that is not approved by the investigator 7. long-term treatment (\> 2 weeks) with agents that have a high risk for nephrotoxicity or hepatotoxicity unless it is approved by the medical monitor 8. receipt of systemic immunosuppressive therapy within 3 months before screening

Keywords: coronavirus
optimal haloperidol dose for postoperative nausea and vomiting prevention in high-risk patients

Conditions: Gynecological Disease

Summary: low-dose haloperidol is known to be effective for the treatment of postoperative nausea and vomiting (ponv). however, precise dose-response studies have not been completed, especially in patients at high risk for ponv who require combination therapy. this study sought to identify the optimal dose of haloperidol that could be combined with dexamethasone without adverse effects in high-risk ponv patients receiving intravenous patient-controlled anesthesia (iv pca) after gynecological laparoscopic surgery.

female adults with three established ponv risk factors based on apfel's score were randomised into one of three study groups. at the end of anaesthesia, groups h0, h1, and h2 were given intravenous (iv) saline, haloperidol 1 mg, and haloperidol 2 mg, respectively. all patients were given dexamethasone during the induction of anaesthesia. the overall early (0-2 h) and late (2-24 h) incidences of nausea, vomiting, rescue anti-emetic administration, pain, and adverse effects (cardiac arrhythmias and extrapyramidal effects) were assessed postoperatively. the sedation score was recorded in the postanaesthesia care unit (pacu).

Eligibility criteria:
inclusion criteria: * asa physical status i or ii women * aged 20 65 years, and scheduled for gynecologic laparoscopic surgery and iv patient-controlled analgesia (pca) for postoperative pain control. exclusion criteria: * known allergy or intolerance to the study drug * history of cardiac arrhythmia * psychiatric illness * chronic treatment with a dopamine antagonist * use of opioids or steroids within one week of surgery * use of antiemetic within 24 hours before the study * no ability to use the pca device * gastrointestinal, renal, or hepatic disease * insulin-dependent diabetes or obesity with a body mass index \> 35 kg/m2.

Keywords: non-smoker female iv pca patient-controlled analgesia
reducing weight and elevated stress levels using educational and behavioral tools

Conditions: Obesity

Summary: the purpose of this protocol is to test the effects on weight of an evidence-based behavioral weight loss program enhanced with culturally targeted stress management strategies compared to the evidence-based weight loss program alone among adult black females with obesity and elevated stress levels. participants will be randomized to receive either a behavioral weight loss intervention with a focus on stress management or the weight loss intervention alone for 26 sessions.


Eligibility criteria:
inclusion criteria: * bmi of at least 30 kg/m\^2 * elevated stress levels based on perceived stress scale score * self-identified as black race exclusion criteria: * pregnant or are planning to become pregnant in the next year * known major medical or psychological condition known to influence body weight loss (e.g., medicated or poorly controlled diabetes (fasting blood glucose \> 126 mg/dl), cardiovascular event in the preceding 12 months, history of gastric bypass surgery, bariatric surgery, or eating disorder) * history of psychiatric hospitalization in past 2 years * history of substance abuse or eating disorder * any condition for which a medical professional has suggested diet modification, physical activity, and/or weight reduction would be contraindicated. * currently taking medications for weight loss
combining topical imiquimod with local radiotherapy for treatment of mycosis fungoides

Conditions: Mycosis Fungoides

Summary: mycosis fungoides (mf) is the most common subtype of cutaneous t cell lymphoma (mf) and presents as cutaneous patches, plaques, and tumors. radiation therapy (rt) is a frequently pursued management option for ctcl, especially in patients with more advanced skin disease. imiquimod stimulates a th1 lymphocyte response with increased il-2 and ifn-α, but also induces ifn-α, tnf-α, il-1α, il-6, and il-8, thereby bridging both innate and adaptive immunity. dosing of both radiotherapy (rt) and imiquimod are based on standard-of-care doses/frequencies for ctcl. the reason imiquimod topical is given for a week before giving rt is to prime innate immune activity for when rt is delivered. it is believed that this serves as an adjuvant for the cd8+ antitumor response generated by rt. the primary aim of this study is to assess the safety and efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (cd4+) mf.


Eligibility criteria:
inclusion criteria: * patients must have confirmed stage ia-iib mycosis fungoides. * patients must be 18-90 years of age. * patients must have failed at least one standard therapy for mf. * patients must have active, but stable disease for \>6 months. * patients must have 4 or more discrete mf lesions with at least 2 of them with minimum combined surface area of \>50cm2. * pocbp must have a negative pregnancy test prior to registration on study. * patients must have the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * patients who are on current systemic or topical ctcl therapy, unless stable on the treatment for \>6 months. * patients who have received antibiotic therapy within 4 weeks of study enrollment. * patients who are pregnant or nursing. pregnant people are excluded from this study because imq is an agent with potential for teratogenic or abortifacient effects. because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the gestational parent with imq, breastfeeding should be discontinued if the parent is treated with imq. * patients with psychiatric illness/social situations that would limit compliance with study requirements.